Denali Therapeutics announces discontinuation of Alzheimer’s drug trial

Key takeaways:

• Results of an ascending dose phase 1 study revealed adverse safety signals at the highest dosage given to volunteers.
• No serious adverse events or treatment-emergent adverse events were reported.

A Bay Area clinical research and development firm announced it will discontinue development of a novel therapeutic for Alzheimer’s disease.

According to a release from Denali Therapeutics, the decision was made along with its partner, Takeda, regarding TAK-920/DNL919 after data from a single ascending dose phase 1 study involving healthy volunteers revealed that, while well-tolerated at doses with demonstrable changes in cerebrospinal fluid biomarkers, safety signals of moderate, reversible hematologic effects were observed at the highest dose tested.

Although the company further stated no serious adverse events or treatment-emergent adverse events were recorded during the trial, analysis suggests a narrow therapeutic window for efficacy of the drug in those with AD. The safety findings are believed to be specific to properties of the therapeutic itself, per the release.

“On our partnered programs, we and Takeda have made a strategic decision to

discontinue development of TAK-920/DNL919 in Alzheimer’s disease based on data from the Phase 1 study and the rapidly evolving treatment landscape,” Denali CEO Ryan Watts, PhD, said in the release. “We will continue to explore backup molecules, including potential combination therapies in Alzheimer’s disease.”

Editor’s note: The headline of this story was updated Aug. 15, 2023.